Menopause Studies Scramble for Funds

By Molly M. Ginty

WeNews correspondent

Friday, August 12, 2005

A growing number of women who once took hormone therapy are now taking black cohosh and eating soy foods to treat menopause. Major studies of the two therapies, however, are scrambling for needed funds.

Subhead:

A growing number of women who once took hormone therapy are now taking black cohosh and eating soy foods to treat menopause. Major studies of the two therapies, however, are scrambling for needed funds.

Byline:

Molly M. Ginty

(WOMENSENEWS)--Just when she thought she was nearly done, Fredi Kronenberg was back at square one.

The director of The Richard and Hinda Rosenthal Center for Complementary and Alternative Medicine at Columbia University in New York City, Kronenberg recently learned that two women's health studies she oversees will not receive government funding they need for completion.

The first study examines black cohosh, the herbal remedy, as an alternative treatment for hot flashes and other symptoms of menopause. The second investigates whether diets high in soy and other foods that mimic the effects of the female hormone estrogen can protect against breast cancer and bone loss.

Both studies are slated to run for a year, are three-quarters of the way finished and have received a combined $1.65 million in support from the Bethesda-based National Institutes of Health. But due to a lack of sufficient resources, these studies will not receive supplemental funding that their supporters were hoping for. Both studies will likely end by October if an additional $650,000 cannot be obtained.

"Times are changing, competition for research funding is on the rise and scientists simply can't rely on the government any more," says Kronenberg.

Kronenberg is working to raise needed funds by approaching women's health groups, individual donors and private foundations and calling for their support. By the end of September, she and her colleagues hope to raise $250,000 (nearly half of the total they need) so they can continue both studies without interruption.

Reflecting a Trend

Health advocates say the plight of the black cohosh and soy studies reflects a growing trend. "Our government is fighting a war instead of funding research and everyone in the scientific field is getting hit hard," says Marcia Stefanick, a professor of medicine at Stanford University in Stanford, Calif.

In June, Congress cut the budget of the Atlanta-based Centers for Disease Control and Prevention by $295 million to $6.1 billion for the fiscal year 2006. Though Congress increased the budget of the Bethesda-based National Institutes of Health by $142 million to $28.5 billion, this represents a smaller increase than in previous years, meaning there is insufficient money to complete some research projects that have no guarantee of continued funding but that are already in progress.

All told, federal funding for scientific research will inch up 0.1 percent for 2006, translating into a total budget of $132 billion. But in previous years, the government has devoted significantly more support to this research, boosting total spending by 14.5 percent in 2003, 6.9 percent in 2004 and 4.6 percent in 2005.

Alarm Raised in 2002

Women's health experts say the Columbia University studies are needed in the wake of the recent discovery that hormone therapy--for four decades the standard treatment for hot flashes, vaginal dryness, mood swings and other menopausal symptoms--can boost the risk of breast cancer, heart attacks, strokes and blood clots and that these risks outweigh the drugs' benefits of slight protection against colorectal cancer and bone fractures.

Published in July 2002 in the Journal of the American Medical Association by leaders of the federally funded Women's Health Initiative study, this finding sparked alarm about drugs for menopause (that are taken in an estrogen-progestin combination or an estrogen-only version for women who have had hysterectomies).

The news that these drugs could pose health risks came as a shock to physicians and patients alike, and led to a 40 percent drop in sales of synthetic hormones and a 60 percent drop in the number of women taking hormone therapy.

Today, an estimated one-third of the 18 million women who used to be on hormone therapy are trying other remedies such as low-dose hormone therapy, non-hormonal drugs and alterative remedies such as black cohosh and soy products.

Black cohosh (cimicifuga racemosa in Latin) is an herb native to the northeastern United States and has been used for decades in the United States and in Europe to treat hot flashes, night sweats and mood swings. Several controlled trials have shown the herb can improve menopausal symptoms for up to six months. The Columbia trial, involving 65 women, examines how daily doses of black cohosh can affect bone density, memory, cognitive functioning, and the frequency and intensity of hot flashes.

Phytoestrogens (found in soybeans, lentils, flaxseed and whole grains) mimic the effects of the hormone estrogen, which declines after menopause. Some studies show phytoestrogens may lessen the risk of heart disease, breast cancer and osteoporosis or bone loss. Columbia's CHOICE Study (Comparing Healthy Options in Cooking and Eating) involves 86 women and aims to continue this research with a multifaceted approach including cooking classes and careful measurements of subjects' rates of bone loss, blood vessel function and estrogen levels.

Women's Health Research Under Threat

Since the news about hormone therapy hit headlines three years ago, a growing number of older women are taking black cohosh and eating soy foods, both of which can be purchased without a doctor's prescription. But scientists are only beginning to study the long-term safety and efficacy of these alternative remedies. They have yet to determine what doses, if any, are appropriate, and what the side effects of taking these products might be.

"Without funding, knowledge so critical to health care decision making for women will be lost, as these projects will come to a halt," says Kronenberg.

Wulf Utian, director of the North American Menopause Society in Mayfield Heights, Ohio, says the loss of the Columbia University research "would be a shame."

Amy Allina, program director for the Washington-based National Women's Health Network, worries about the future of all kinds of women's health studies.

"Certain areas of women's health research have long been under-funded," she says. "Contraceptive development has been languishing for years. And the development of micro-biocides--products that may help women protect themselves against HIV--continues to get only a small portion of federal funding even though it merits much more attention. Now we're even more concerned that politically controversial areas won't get the support they need."

In response to the recent threats to scientific research, the Washington-based Society for Women's Health Research has lobbied Congress to continue funding the NIH's Office of Research on Women's Health and to boost funding for the Food and Drug Administration's Office of Women's Health and the Department of Health and Human Services' Office on Women's Health.

Meanwhile, the Washington-based Coalition to Protect Research is sending congressional representatives petitions that prove their constituents support scientific research.

"Women are not only lobbying for more government funding, but are working to boost private funding for women's health initiatives," says Columbia's Fredi Kronenberg. "We are fighting our best to support research, but we still have a long way to go."